# US 9,433,500 B2 · Prosthetic valve for replacing mitral valve

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- Number: US 9,433,500 B2
- Document ID: US9433500B2
- Status: Granted
- Kind: B2
- Application number: 14/801,713
- Filed: 2015-07-16
- Published: 2015-11-12
- Granted: 2016-09-06
- Earliest claimed: 2009-12-04
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Mark Chau; Marlowe E. Patterson; Seung-Beom Yi; Stephen C. Geist; Travis Oba
- Web page: https://patentgrep.com/patent/US9433500B2

## CPC

- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0069: cylindrical
- A61F 2250/006: modular
- A61F 2250/0063: Nested prosthetic parts
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A prosthetic apparatus configured for implantation in the native mitral valve region of the heart includes a main body that is self-expandable from a compressed state to a radially expanded state. The prosthetic apparatus comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body for capturing a native valve leaflet between the anchor and an outer surface of the main body. In one preferred method of implantation, the prosthetic apparatus is rotated within the native mitral valve region such that a portion of the anchor moves horizontally behind adjacent chordae for anchoring the prosthetic apparatus in the native mitral valve.

## Claims

### Claim 1

A method of implanting a prosthetic apparatus in a defective native mitral valve without requiring open heart surgery or cardiopulmonary bypass, the method comprising:
advancing a prosthetic apparatus toward a mitral valve annulus, the prosthetic apparatus comprising a main body in a radially compressed state and a valve structure supported within the main body, the prosthetic apparatus further comprising at least one ventricular anchor coupled to the main body and disposed outside the main body;
guiding the ventricular anchor between chordae and behind a native mitral valve leaflet;
rotating the prosthetic apparatus such that the ventricular anchor moves horizontally behind chordae for capturing chordae between the ventricular anchor and the main body; and
allowing the main body to expand from the radially compressed state to a radially expanded state within the mitral valve annulus;
wherein, after implantation, chordae are positioned between the ventricular anchor and the main body for securing the prosthetic apparatus in the mitral valve annulus.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ventricular anchor extends upwardly from an outflow end of the main body.

### Claim 3 (depends on 1)

The method of claim 1, wherein the ventricular anchor comprises a vertical leg portion and a horizontal foot portion.

### Claim 4 (depends on 3)

The method of claim 3, wherein the horizontal foot portion is curved for wrapping around the main body.

### Claim 5 (depends on 1)

The method of claim 1, wherein the valve structure comprises pericardial tissue.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least one ventricular anchor comprises a plurality of ventricular anchors.

### Claim 7 (depends on 1)

The method of claim 1, wherein the prosthetic apparatus further comprises an atrial sealing member adapted for placement above the mitral valve annulus.

### Claim 8 (depends on 1)

The method of claim 1, wherein the prosthetic apparatus comprises a shape-memory material.

### Claim 9 (depends on 1)

The method of claim 1, wherein the prosthetic apparatus is advanced toward the mitral valve annulus using a catheter.

### Claim 10 (depends on 9)

The method of claim 9, wherein the catheter is steerable.

### Claim 11 (depends on 9)

The method of claim 9, wherein the prosthetic apparatus is advanced using a transatrial approach.

### Claim 12 (depends on 9)

The method of claim 9, wherein the prosthetic apparatus is advanced using a transseptal approach.

### Claim 13

A method of implanting a prosthetic apparatus in a defective native mitral valve without requiring open heart surgery or cardiopulmonary bypass, the method comprising:
advancing a prosthetic apparatus toward a mitral valve annulus, the prosthetic apparatus comprising a radially collapsible and expandable main body and a valve structure supported within the main body, the prosthetic apparatus further comprising first and second ventricular anchors coupled to the main body and disposed outside the main body;
guiding the first ventricular anchor behind an anterior leaflet of the native mitral valve;
guiding the second ventricular anchor behind a posterior leaflet of the native mitral valve;
rotating the prosthetic apparatus such that portions of the ventricular anchors move horizontally for capturing chordae between the ventricular anchors and the main body; and
allowing the main body to radially expand from a compressed state to an expanded state within the mitral valve annulus.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first and second ventricular anchors are coupled to an outflow end of the main body.

### Claim 15 (depends on 13)

The method of claim 13, wherein the first and second ventricular anchors each comprises a vertical leg portion and a horizontal foot portion, the horizontal portion terminating in an engagement portion.

### Claim 16 (depends on 15)

The method of claim 15, wherein the horizontal foot portions wrap around the main body.

### Claim 17 (depends on 13)

The method of claim 13, wherein the valvular structure comprises pericardial tissue.

### Claim 18 (depends on 13)

The method of claim 13, wherein the prosthetic apparatus further comprises an atrial sealing member for placement above the mitral valve annulus.

### Claim 19 (depends on 13)

The method of claim 13, wherein the prosthetic apparatus comprises a shape-memory material.

### Claim 20 (depends on 13)

The method of claim 13, wherein the prosthetic apparatus is advanced across the septum and toward the mitral valve annulus using a catheterization technique.